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Nonmedical Switching From Originators to Biosimilars: Does the Nocebo Effect Explain Treatment Failures and Adverse Events in Rheumatology and Gastroenterology?

Fleischmann R, Jairath V, Mysler E, Nicholls D, Declerck P.

Rheumatol Ther. 2020 Jan 16. doi: 10.1007/s40744-019-00190-7. [Epub ahead of print] Review.


Tofacitinib in combination with methotrexate in patients with rheumatoid arthritis: patient-reported outcomes from the 24-month Phase 3 ORAL Scan study.

Strand V, van der Heijde D, Tanaka Y, Keystone E, Kremer J, Zerbini CAF, Cardiel MH, Cohen S, Nash P, Song YW, Tegzová D, Gruben D, Wallenstein G, Connell CA, Fleischmann R; ORAL Scan investigators.

Clin Exp Rheumatol. 2019 Dec 19. [Epub ahead of print]


Looking Back on 2019 in Rheumatology and What to Expect from 2020.

Fleischmann R.

Rheumatol Ther. 2019 Dec 10. doi: 10.1007/s40744-019-00188-1. [Epub ahead of print] No abstract available.


Disease activity improvements with optimal discriminatory ability between treatment arms: applicability in early and established rheumatoid arthritis clinical trials.

Smolen J, Fleischmann R, Aletaha D, Li Y, Zhou Y, Sainsbury I, Galindo IL.

Arthritis Res Ther. 2019 Nov 10;21(1):231. doi: 10.1186/s13075-019-2005-9.


Patient-reported outcomes for tofacitinib with and without methotrexate, or adalimumab with methotrexate, in rheumatoid arthritis: a phase IIIB/IV trial.

Strand V, Mysler E, Moots RJ, Wallenstein GV, DeMasi R, Gruben D, Soma K, Iikuni N, Smolen JS, Fleischmann R.

RMD Open. 2019 Oct 1;5(2):e001040. doi: 10.1136/rmdopen-2019-001040. eCollection 2019.


Quantitative Signal Intensity in Fluid-Attenuated Inversion Recovery and Treatment Effect in the WAKE-UP Trial.

Cheng B, Boutitie F, Nickel A, Wouters A, Cho TH, Ebinger M, Endres M, Fiebach JB, Fiehler J, Galinovic I, Puig J, Thijs V, Lemmens R, Muir KW, Nighoghossian N, Pedraza S, Simonsen CZ, Gerloff C, Thomalla G; WAKE-UP (Efficacy and Safety of MRI-Based Thrombolysis inWake-Up Stroke Trial) investigators and administrative staff are as follows:.

Stroke. 2020 Jan;51(1):209-215. doi: 10.1161/STROKEAHA.119.027390. Epub 2019 Oct 30.


Efficacy of Abatacept and Adalimumab in Patients with Early Rheumatoid Arthritis With Multiple Poor Prognostic Factors: Post Hoc Analysis of a Randomized Controlled Clinical Trial (AMPLE).

Fleischmann R, Weinblatt M, Ahmad H, Maldonado MA, Alemao E, Ye J, Schiff M.

Rheumatol Ther. 2019 Dec;6(4):559-571. doi: 10.1007/s40744-019-00174-7. Epub 2019 Oct 22.


Estimating Lyapunov exponents in billiards.

Datseris G, Hupe L, Fleischmann R.

Chaos. 2019 Sep;29(9):093115. doi: 10.1063/1.5099446.


Leucine Supplementation Does Not Restore Diminished Skeletal Muscle Satellite Cell Abundance and Myonuclear Accretion When Protein Intake Is Limiting in Neonatal Pigs.

Rudar M, Columbus DA, Steinhoff-Wagner J, Suryawan A, Nguyen HV, Fleischmann R, Davis TA, Fiorotto ML.

J Nutr. 2020 Jan 1;150(1):22-30. doi: 10.1093/jn/nxz216.


Vascular Health of Children Conceived via In Vitro Fertilization.

Zhang WY, Selamet Tierney ES, Chen AC, Ling AY, Fleischmann RR, Baker VL.

J Pediatr. 2019 Nov;214:47-53. doi: 10.1016/j.jpeds.2019.07.033. Epub 2019 Aug 20.


Safety and effectiveness of upadacitinib or adalimumab plus methotrexate in patients with rheumatoid arthritis over 48 weeks with switch to alternate therapy in patients with insufficient response.

Fleischmann RM, Genovese MC, Enejosa JV, Mysler E, Bessette L, Peterfy C, Durez P, Ostor A, Li Y, Song IH.

Ann Rheum Dis. 2019 Nov;78(11):1454-1462. doi: 10.1136/annrheumdis-2019-215764. Epub 2019 Jul 30.


Long-term safety of sarilumab in rheumatoid arthritis: an integrated analysis with up to 7 years' follow-up.

Fleischmann R, Genovese MC, Lin Y, St John G, van der Heijde D, Wang S, Gomez-Reino JJ, Maldonado-Cocco JA, Stanislav M, Kivitz AJ, Burmester GR.

Rheumatology (Oxford). 2020 Feb 1;59(2):292-302. doi: 10.1093/rheumatology/kez265.


Dr. Fleischmann replies.

Fleischmann R.

J Rheumatol. 2019 Dec;46(12):1642. doi: 10.3899/jrheum.190603. Epub 2019 Jul 15. No abstract available.


Upadacitinib Versus Placebo or Adalimumab in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate: Results of a Phase III, Double-Blind, Randomized Controlled Trial.

Fleischmann R, Pangan AL, Song IH, Mysler E, Bessette L, Peterfy C, Durez P, Ostor AJ, Li Y, Zhou Y, Othman AA, Genovese MC.

Arthritis Rheumatol. 2019 Nov;71(11):1788-1800. doi: 10.1002/art.41032. Epub 2019 Aug 28.


Efficacy and safety of long-term baricitinib with and without methotrexate for the treatment of rheumatoid arthritis: experience with baricitinib monotherapy continuation or after switching from methotrexate monotherapy or baricitinib plus methotrexate.

Fleischmann R, Takeuchi T, Schiff M, Schlichting D, Xie L, Issa M, Stoykov I, Lisse J, Martinez-Osuna P, Rooney T, Zerbini CAF.

Arthritis Care Res (Hoboken). 2019 Jun 24. doi: 10.1002/acr.24007. [Epub ahead of print]


Achieving Pain Control in Rheumatoid Arthritis with Baricitinib or Adalimumab Plus Methotrexate: Results from the RA-BEAM Trial.

Taylor PC, Lee YC, Fleischmann R, Takeuchi T, Perkins EL, Fautrel B, Zhu B, Quebe AK, Gaich CL, Zhang X, Dickson CL, Schlichting DE, Patel H, Durand F, Emery P.

J Clin Med. 2019 Jun 12;8(6). pii: E831. doi: 10.3390/jcm8060831.


Live Zoster Vaccine in Patients with Rheumatoid Arthritis Treated with Tofacitinib with or without Methotrexate, or Adalimumab with Methotrexate.

Calabrese LH, Abud-Mendoza C, Lindsey SM, Lee SH, Tatulych S, Takiya L, Iikuni N, Soma K, Luo Z, Fleischmann R.

Arthritis Care Res (Hoboken). 2019 Jun 17. doi: 10.1002/acr.24010. [Epub ahead of print]


Maternal and neonatal outcomes associated with trophectoderm biopsy.

Zhang WY, von Versen-Höynck F, Kapphahn KI, Fleischmann RR, Zhao Q, Baker VL.

Fertil Steril. 2019 Aug;112(2):283-290.e2. doi: 10.1016/j.fertnstert.2019.03.033. Epub 2019 May 15.


Value of the Multibiomarker Disease Activity Score to Predict Remission in RA: What Does the Evidence Show?

Fleischmann R.

J Rheumatol. 2019 May;46(5):443-446. doi: 10.3899/jrheum.181061. No abstract available.


Motor Task-Dependent Dissociated Effects of Transcranial Random Noise Stimulation in a Finger-Tapping Task Versus a Go/No-Go Task on Corticospinal Excitability and Task Performance.

Jooss A, Haberbosch L, Köhn A, Rönnefarth M, Bathe-Peters R, Kozarzewski L, Fleischmann R, Scholz M, Schmidt S, Brandt SA.

Front Neurosci. 2019 Feb 27;13:161. doi: 10.3389/fnins.2019.00161. eCollection 2019.


Postnatal undernutrition alters adult female mouse cardiac structure and function leading to limited exercise capacity.

Ferguson DP, Monroe TO, Heredia CP, Fleischmann R, Rodney GG, Taffet GE, Fiorotto ML.

J Physiol. 2019 Apr;597(7):1855-1872. doi: 10.1113/JP277637. Epub 2019 Mar 3.


Tofacitinib in Combination With Methotrexate in Patients With Rheumatoid Arthritis: Clinical Efficacy, Radiographic, and Safety Outcomes From a Twenty-Four-Month, Phase III Study.

van der Heijde D, Strand V, Tanaka Y, Keystone E, Kremer J, Zerbini CAF, Cardiel MH, Cohen S, Nash P, Song YW, Tegzová D, Gruben D, Wallenstein G, Connell CA, Fleischmann R; ORAL Scan Investigators.

Arthritis Rheumatol. 2019 Jun;71(6):878-891. doi: 10.1002/art.40803. Epub 2019 Apr 24.


A Phase II Trial of Lutikizumab, an Anti-Interleukin-1α/β Dual Variable Domain Immunoglobulin, in Knee Osteoarthritis Patients With Synovitis.

Fleischmann RM, Bliddal H, Blanco FJ, Schnitzer TJ, Peterfy C, Chen S, Wang L, Feng S, Conaghan PG, Berenbaum F, Pelletier JP, Martel-Pelletier J, Vaeterlein O, Kaeley GS, Liu W, Kosloski MP, Levy G, Zhang L, Medema JK, Levesque MC.

Arthritis Rheumatol. 2019 Jul;71(7):1056-1069. doi: 10.1002/art.40840. Epub 2019 Jun 7.


Increased Preeclampsia Risk and Reduced Aortic Compliance With In Vitro Fertilization Cycles in the Absence of a Corpus Luteum.

von Versen-Höynck F, Schaub AM, Chi YY, Chiu KH, Liu J, Lingis M, Stan Williams R, Rhoton-Vlasak A, Nichols WW, Fleischmann RR, Zhang W, Winn VD, Segal MS, Conrad KP, Baker VL.

Hypertension. 2019 Mar;73(3):640-649. doi: 10.1161/HYPERTENSIONAHA.118.12043.


Delirium is associated with frequency band specific dysconnectivity in intrinsic connectivity networks: preliminary evidence from a large retrospective pilot case-control study.

Fleischmann R, Traenkner S, Kraft A, Schmidt S, Schreiber SJ, Brandt SA.

Pilot Feasibility Stud. 2019 Jan 7;5:2. doi: 10.1186/s40814-018-0388-z. eCollection 2019.


A Summary of 2018 and What Lies Ahead for Rheumatology and Therapy in 2019.

Fleischmann R.

Rheumatol Ther. 2019 Mar;6(1):1-3. doi: 10.1007/s40744-018-0136-0. Epub 2019 Jan 5. No abstract available.


Phase IIa, placebo-controlled, randomised study of lutikizumab, an anti-interleukin-1α and anti-interleukin-1β dual variable domain immunoglobulin, in patients with erosive hand osteoarthritis.

Kloppenburg M, Peterfy C, Haugen IK, Kroon F, Chen S, Wang L, Liu W, Levy G, Fleischmann RM, Berenbaum F, van der Heijde D, Bansal P, Wittoek R, Feng S, Fang Y, Saltarelli M, Medema JK, Levesque MC.

Ann Rheum Dis. 2019 Mar;78(3):413-420. doi: 10.1136/annrheumdis-2018-213336. Epub 2018 Dec 14.


Efficacy of Tofacitinib for the Treatment of Psoriatic Arthritis: Pooled Analysis of Two Phase 3 Studies.

Nash P, Coates LC, Fleischmann R, Papp KA, Gomez-Reino JJ, Kanik KS, Wang C, Wu J, Menon S, Hendrikx T, Ports WC.

Rheumatol Ther. 2018 Dec;5(2):567-582. doi: 10.1007/s40744-018-0131-5. Epub 2018 Nov 9.


A pooled analysis of the safety of tofacitinib as monotherapy or in combination with background conventional synthetic disease-modifying antirheumatic drugs in a Phase 3 rheumatoid arthritis population.

Kivitz AJ, Cohen S, Keystone E, van Vollenhoven RF, Haraoui B, Kaine J, Fan H, Connell CA, Bananis E, Takiya L, Fleischmann R.

Semin Arthritis Rheum. 2018 Dec;48(3):406-415. doi: 10.1016/j.semarthrit.2018.07.006. Epub 2018 Jul 19.


Distinguishing rheumatoid arthritis from psoriatic arthritis.

Merola JF, Espinoza LR, Fleischmann R.

RMD Open. 2018 Aug 13;4(2):e000656. doi: 10.1136/rmdopen-2018-000656. eCollection 2018.


Patients' experiences in a guided Internet- and App-based stress intervention for college students: A qualitative study.

Fleischmann RJ, Harrer M, Zarski AC, Baumeister H, Lehr D, Ebert DD.

Internet Interv. 2017 Dec 29;12:130-140. doi: 10.1016/j.invent.2017.12.001. eCollection 2018 Jun.


A comparative clinical study of PF-06410293, a candidate adalimumab biosimilar, and adalimumab reference product (Humira®) in the treatment of active rheumatoid arthritis.

Fleischmann RM, Alten R, Pileckyte M, Lobello K, Hua SY, Cronenberger C, Alvarez D, Bock AE, Sewell KL.

Arthritis Res Ther. 2018 Aug 15;20(1):178. doi: 10.1186/s13075-018-1676-y.


Structural damage progression in patients with early rheumatoid arthritis treated with methotrexate, baricitinib, or baricitinib plus methotrexate based on clinical response in the phase 3 RA-BEGIN study.

van der Heijde D, Durez P, Schett G, Naredo E, Østergaard M, Meszaros G, De Leonardis F, de la Torre I, López-Romero P, Schlichting D, Nantz E, Fleischmann R.

Clin Rheumatol. 2018 Sep;37(9):2381-2390. doi: 10.1007/s10067-018-4221-0. Epub 2018 Aug 4.


Safety and efficacy of upadacitinib in patients with active rheumatoid arthritis refractory to biologic disease-modifying anti-rheumatic drugs (SELECT-BEYOND): a double-blind, randomised controlled phase 3 trial.

Genovese MC, Fleischmann R, Combe B, Hall S, Rubbert-Roth A, Zhang Y, Zhou Y, Mohamed MF, Meerwein S, Pangan AL.

Lancet. 2018 Jun 23;391(10139):2513-2524. doi: 10.1016/S0140-6736(18)31116-4. Epub 2018 Jun 18.


MRI-Guided Thrombolysis for Stroke with Unknown Time of Onset.

Thomalla G, Simonsen CZ, Boutitie F, Andersen G, Berthezene Y, Cheng B, Cheripelli B, Cho TH, Fazekas F, Fiehler J, Ford I, Galinovic I, Gellissen S, Golsari A, Gregori J, Günther M, Guibernau J, Häusler KG, Hennerici M, Kemmling A, Marstrand J, Modrau B, Neeb L, Perez de la Ossa N, Puig J, Ringleb P, Roy P, Scheel E, Schonewille W, Serena J, Sunaert S, Villringer K, Wouters A, Thijs V, Ebinger M, Endres M, Fiebach JB, Lemmens R, Muir KW, Nighoghossian N, Pedraza S, Gerloff C; WAKE-UP Investigators.

N Engl J Med. 2018 Aug 16;379(7):611-622. doi: 10.1056/NEJMoa1804355. Epub 2018 May 16.


Effectiveness of an Internet- and App-Based Intervention for College Students With Elevated Stress: Randomized Controlled Trial.

Harrer M, Adam SH, Fleischmann RJ, Baumeister H, Auerbach R, Bruffaerts R, Cuijpers P, Kessler RC, Berking M, Lehr D, Ebert DD.

J Med Internet Res. 2018 Apr 23;20(4):e136. doi: 10.2196/jmir.9293.


Pharmacodynamic and pharmacokinetic effects and safety of verinurad in combination with febuxostat in adults with gout: a phase IIa, open-label study.

Fleischmann R, Winkle P, Hall J, Valdez S, Liu S, Yan X, Hicks L, Lee C, Miner JN, Gillen M, Hernandez-Illas M.

RMD Open. 2018 Apr 9;4(1):e000647. doi: 10.1136/rmdopen-2018-000647. eCollection 2018.


Diagnostic Performance and Utility of Quantitative EEG Analyses in Delirium: Confirmatory Results From a Large Retrospective Case-Control Study.

Fleischmann R, Tränkner S, Bathe-Peters R, Rönnefarth M, Schmidt S, Schreiber SJ, Brandt SA.

Clin EEG Neurosci. 2018 Mar 1:1550059418767584. doi: 10.1177/1550059418767584. [Epub ahead of print]


4-year results from the RAPID-PsA phase 3 randomised placebo-controlled trial of certolizumab pegol in psoriatic arthritis.

van der Heijde D, Deodhar A, FitzGerald O, Fleischmann R, Gladman D, Gottlieb AB, Hoepken B, Bauer L, Irvin-Sellers O, Khraishi M, Peterson L, Turkiewicz A, Wollenhaupt J, Mease PJ.

RMD Open. 2018 Mar 14;4(1):e000582. doi: 10.1136/rmdopen-2017-000582. eCollection 2018. Erratum in: RMD Open. 2018 Mar 26;4(1):.


Pharmacodynamic and pharmacokinetic effects and safety of verinurad in combination with allopurinol in adults with gout: a phase IIa, open-label study.

Fleischmann R, Winkle P, Miner JN, Yan X, Hicks L, Valdez S, Hall J, Liu S, Shen Z, Gillen M, Hernandez-Illas M.

RMD Open. 2018 Feb 8;4(1):e000584. doi: 10.1136/rmdopen-2017-000584. eCollection 2018.


Worldwide, 3-Year, Post-Marketing Surveillance Experience with Tofacitinib in Rheumatoid Arthritis.

Cohen S, Curtis JR, DeMasi R, Chen Y, Fan H, Soonasra A, Fleischmann R.

Rheumatol Ther. 2018 Jun;5(1):283-291. doi: 10.1007/s40744-018-0097-3. Epub 2018 Feb 22.


Safety and maintenance of response for tofacitinib monotherapy and combination therapy in rheumatoid arthritis: an analysis of pooled data from open-label long-term extension studies.

Fleischmann R, Wollenhaupt J, Takiya L, Maniccia A, Kwok K, Wang L, van Vollenhoven RF.

RMD Open. 2017 Dec 18;3(2):e000491. doi: 10.1136/rmdopen-2017-000491. eCollection 2017.


Effect of Discontinuation or Initiation of Methotrexate or Glucocorticoids on Tofacitinib Efficacy in Patients with Rheumatoid Arthritis: A Post Hoc Analysis.

Fleischmann R, Wollenhaupt J, Cohen S, Wang L, Fan H, Bandi V, Andrews J, Takiya L, Bananis E, Weinblatt ME.

Rheumatol Ther. 2018 Jun;5(1):203-214. doi: 10.1007/s40744-018-0093-7. Epub 2018 Feb 7.


Editorial: The American College of Rheumatology White Paper on Biosimilars: It Isn't All White-There Is Some Gray and Black.

Fleischmann R.

Arthritis Rheumatol. 2018 Mar;70(3):323-325. doi: 10.1002/art.40402. Epub 2018 Feb 7. No abstract available.


Mobile electronic versus paper case report forms in clinical trials: a randomized controlled trial.

Fleischmann R, Decker AM, Kraft A, Mai K, Schmidt S.

BMC Med Res Methodol. 2017 Dec 1;17(1):153. doi: 10.1186/s12874-017-0429-y.


Testing treat-to-target outcomes with initial methotrexate monotherapy compared with initial tumour necrosis factor inhibitor (adalimumab) plus methotrexate in early rheumatoid arthritis.

Kavanaugh A, van Vollenhoven RF, Fleischmann R, Emery P, Sainsbury I, Florentinus S, Chen S, Guérette B, Kupper H, Smolen JS.

Ann Rheum Dis. 2018 Feb;77(2):289-292. doi: 10.1136/annrheumdis-2017-211871. Epub 2017 Nov 16.


Effect of Glucocorticoids on the Clinical and Radiographic Efficacy of Tofacitinib in Patients with Rheumatoid Arthritis: A Posthoc Analysis of Data from 6 Phase III Studies.

Charles-Schoeman C, van der Heijde D, Burmester GR, Nash P, Zerbini CAF, Connell CA, Fan H, Kwok K, Bananis E, Fleischmann R.

J Rheumatol. 2018 Feb;45(2):177-187. doi: 10.3899/jrheum.170486. Epub 2017 Nov 15.


Therapy: Biosimilars in rheumatology - why, how and when in 2017.

Fleischmann R.

Nat Rev Rheumatol. 2017 Dec;13(12):701-703. doi: 10.1038/nrrheum.2017.179. Epub 2017 Nov 3. No abstract available.


Safety and efficacy of baricitinib in elderly patients with rheumatoid arthritis.

Fleischmann R, Alam J, Arora V, Bradley J, Schlichting DE, Muram D, Smolen JS.

RMD Open. 2017 Oct 10;3(2):e000546. doi: 10.1136/rmdopen-2017-000546. eCollection 2017. No abstract available.


Tofacitinib in the treatment of active rheumatoid arthritis in adults.

Fleischmann R.

Immunotherapy. 2018 Jan;10(1):39-56. doi: 10.2217/imt-2017-0118. Epub 2017 Oct 18. Review.


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